All drugs have the potential to be misused, whether the drugs are legally prescribed by a physician, or purchased over-the-counter at a store. When ingested in excessive quantities, drugs normally considered safe can cause death or serious bodily damage.
Accidental and purposeful overdose or death by over consumption of drugs is a serious problem. People ingest drugs to attempt suicide and are often successful. People who suffer from depression and who have suicidal thoughts are also at high risk for drug overdose. Drug addicts ingest and consume quantities of drugs to elicit mind and mood altering effects, potentially causing serious injury to their bodies. Children are able to open containers containing any variety of drugs and innocently ingest or consume the drugs without knowledge of the consequences, even with the advent of tamper proof containers.
Accidental drug overdose may be the result of misuse of prescription medicines or commonly used medications like pain relievers and cold remedies. Between 1970 and 2000, some 131,000 people died by accidental drug overdose. While a small percentage (3 percent) of the deaths were from adverse effects of the right drug taken at the right dose, 97 percent of the deaths resulted from medication errors including ingesting a wrong dose, or accidental overdose of a drug. According to the National Institute on Drug Abuse, in 1992, almost 6,000 deaths were the result of accidental overdose of psychoactive and other drugs. Patients treated with antidepressant medications, i.e., GSK's WELLBUTRIN® and PAXIL® (paroxetine), Eli Lilly's PROZAC® (fluoxetine), Pfizer's ZOLOFT® (sertraline), Solvay's LUVOX® (fluvoxamine), Forest Laboratories'CELEXA® (citalopram) and LEXAPRO® (escitalopram), Wyeth's EFFEXOR® (venlafaxine), Bristol-Myers Squibb's SERZONE® (nefazodone) and Organon's REMERON® (mirtazapine), may have an increased risk of suicidal thoughts and behaviour.
Accordingly, there is a great need for dosage forms to prevent accidental or intentional overdose of drugs.
It is known in the art that emetics may be incorporated into drug compositions, or admixed with a drug. Following ingestion, the drug and emetic would be simultaneously released in the stomach. However, this requires development of formulations and compositions which are compatible and otherwise suitable for use with both the drug and the emetic, and further requires that the drug and the emetic be chemically compatible with each other. Additionally, combining an emetic and drug in a single composition would cause the emetic and drug to be released simultaneously following ingestion, thus there is a danger that a dangerous or toxic amount of drug can be absorbed into the body prior to emesis of the drug.
U.S. Pat. Nos. 4,175,119 and 4,529,583, herein incorporated by reference, disclose a medicinal composition whereby a tablet or capsule is coated with an emetic to prevent accidental or purposeful drug overdose. However, this requires the use of coating machines which health care professionals may not have access to.
Thus a need exists for an emetic dosage form which may be employed for the delivery of a wide range of drugs and which permits flexibility in dosing of the drug and emetic.
Additionally, a need exists for an emetic dosage form which may be employed for the delivery of a wide range of drugs and which permits customized dosing of the drug and emetic for individual patients.
Additionally, a need exists for a method for manufacturing and administering an emetic dosage form allowing health care professionals to tailor various drugs in variable amounts for individuals that may ingest an overdose of a drug.
Additionally, a need exists for a method to customize an emetic dosage to induce emesis before drugs are absorbed in a human, potentially causing an overdose.